Versions Compared

Old Version 7

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version 8

changes.mady.by.user Christine Connolly

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Metadata tables guide implementation of the CDISC CDASH to build datasets for representation of collected or derived data. Domain specifications for the TIG are provided in the following sections:

HeadingExplanation
Observation Class

This column contains the SDTM class for the domain. 

Domain

This column contains the 2-letter domain code.

Data Collection ScenarioThis column identifies the different data collection options in CDASH for the same domain and is best used for filtering the table. The information in this column provides the context for the CDASHIG Core Designations (e.g., denoting which fields should be present on the CRF). When only 1 data collection scenario is provided for the domain, the column contains "N/A."

Implementation Options 

 When this column contains "Horizontal-Generic," a sampling of the CDASHIG metadata is provided as a template for the metadata of the CRF in a denormalized structure.
Order NumberThe values in this column are used to help sequence the variables as they appear in the metadata table and provide a suggested order of CDASHIG variables to be displayed on a CRF. There is no implied meaning, significance, or conformance expectations. The values increase by 1 for each variable within a unique grouping of Observation Class plus Domain plus Implementation Options. 
CDASHIG Variable

 This column provides the CDASHIG variable names (e.g., CMONGO, AEDAT). 

CDASHIG Variable Label This column provides the CDASHIG variable label.  
DRAFT CDASHIG DefinitionThis column provides a draft definition of the CDASHIG variable. This text may or may not mirror any text in the SDTMIG. Currently, there is a new CDASH/SDTM team creating variable definitions. Once these definitions are finalized, the CDASH definitions will be updated to harmonize with them.
Question TextThis column provides suggested text for the specific domain. Implementers should refer to the CDASH Model to create alternative question text that may be used that meets CDASH conformance rules. Question Text is a complete sentence. Some text is presented inside brackets [ ] or parentheses (). Text inside brackets should be replaced with protocol-specified verbiage; text inside parentheses is optional. Text separated with a forward slash / indicates optional wording from which the sponsor may choose. 

Prompt 

This column provides suggested text for the specific domain. Implementers should refer to the CDASH Model to create alternative prompt text that may be used that meets CDASH conformance rules. Prompt is a short version of the question. Some text is presented inside brackets [ ] or parentheses (). Text inside brackets should be replaced with protocol-specified verbiage. [NULL] in this column indicates that populating a prompt is not required on a CRF screen/page if not needed.

Data Type 

This column contains the simple data type of the CDASH variable (i.e., Char, Num, Date, Time).

CDASHIG Core 

This column contains the CDASHIG core designations for basic data collection fields (i.e., Highly Recommended (HR), Recommended/Conditional (R/C), Optional (O)). See Section 3.2, Core Designations for Basic Data Collection Fields.
Case Report Form Completion InstructionsThis column contains recommended example instructions for the clinical site on how to enter collected information on the CRF.
SDTMIG Target 

This column provides the suggested mapping to the SDTMIG variable name. It may help facilitate the creation of the SDTMIG variables needed for submission. When no direct mapping to an SDTMIG variable is available, the column contains "N/A". When the column contains "SUPP--.QNAM", it means that that the value represented in the CDASH field shall be mapped to an SDTM Supplemental Qualifier.
Note: CDASHIG variables noted as not having a direct map to SDTMIG variables (i.e., NSVs) may have SDTM variable equivalents in future versions.

Mapping Instructions

This column contains information on the suggested mapping of the CDASHIG variable to the SDTMIG variable. Mapping instructions in the CDASHIG metadata tables provide more complete guidance than that in the CDASH Model. When domain-level metadata are not available, consult the CDASH Model for SDTM mapping instructions.

Controlled Terminology Codelist Name 

This column contains the CT codelist name (e.g., "LOC") that is associated with the field. The SDTMIG indicates that certain variables (e.g., dates) use ISO formats as CT. However, in CDASH these variables are generally not collected using ISO CT, but rather are converted to the ISO format when the SDTM-based submission datasets are created.      

Subset Controlled Terminology/CDASH Codelist Name:This column contains the CDISC CT or CDASH subset codelist name that may be used for that specific variable (e.g., EXDOSFRM). 

Implementation Notes 

This column contains further information, such as rationale and implementation instructions, regarding how to implement the CRF data collection fields and how to map CDASHIG variables to SDTMIG variables.

...